On 2 September 2026, Health Canada updated two forms relating to the exceptional importation and sale of medical devices. The changes convert the PDF forms into online forms, add procedural compliance declarations and several new reporting fields, and shorten the pre-arrival notification period from 5 working days to 3 working days.
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I. Background
On 2 September 2026, Health Canada published updated versions of forms relating to the exceptional importation and sale of medical devices, covering the following two forms:
| Form | Primary Purpose |
|---|---|
| FRM-0577 | To apply to add a medical device already authorised for sale in a foreign country to Canada’s “List of Medical Devices for Exceptional Importation and Sale,” or to request a modification to that list |
| FRM-0578 | To notify Health Canada of a shipment of exceptionally imported medical devices that is about to arrive in Canada |
The updated forms further clarify the information Health Canada requires when reviewing exceptional importation and sale applications, helping to streamline the review process and strengthen the handling and tracking of imported goods.
II. What Changes Do Both Forms Share?
Both FRM-0577 and FRM-0578 have undergone the following adjustments:
1. PDF forms converted to online forms
The previous PDF format has been replaced with web-based forms completed online.
2. Attachment uploads now supported
Where information cannot be fully captured in the text fields, applicants may upload attachments. Supported file formats include:
- JPE, JPG, JPEG
- PNG
- DOC, DOCX
- Excel files (listed as “XLXS” in the original document)
- GIF
3. Added procedural or process declarations
The forms now include declarations requiring applicants to confirm, as applicable, that written procedures or processes are in place covering:
- Maintenance of sales records
- Complaint handling
- Incident reporting
- Provision of information on risks that may cause serious harm to human health
- Product recalls
III. What New Reporting Fields Have Been Added to FRM-0577?
FRM-0577 is used primarily to submit an exceptional importation and sale application, or to request a modification to the relevant medical device list.
The updated form includes the following new information fields:
1. Foreign regulatory authority information
The name of the foreign regulatory authority that authorised the sale of the relevant medical device in its jurisdiction.
2. Rationale or supporting evidence for the application
Applicants must provide reasons or evidence supporting the application, including:
- Evidence that a medical device authorised for sale in Canada is currently in shortage or at risk of shortage;
- An explanation of why the device proposed for importation is a suitable substitute for the licensed Canadian product in shortage;
- The proposed final import date for each device identifier;
- The estimated total quantity of the exceptionally imported product for each device identifier.
3. Product supporting documentation
Supporting documents to be submitted include:
- The intended use of the medical device proposed for importation;
- Information on the safe use of the product;
- A valid foreign marketing authorisation;
- A valid Quality Management System (QMS) certification held by the manufacturer.
Health Canada may also require importers to provide additional information or documents on a case-by-case basis.
IV. What Are the Key Changes to FRM-0578?
FRM-0578 is used to report shipments of exceptionally imported medical devices arriving in Canada. This update involves two main changes.
1. Shorter pre-arrival notification period
Importers must notify Health Canada 3 working days before the shipment is expected to arrive at the Canadian port of entry. The previous notification period was 5 working days before arrival.
2. Added product tracking information
The form now includes the following fields:
- Product lot number;
- Product expiry date.
This adjustment further clarifies the identification and tracking requirements for exceptionally imported shipments.
V. Recommendations for Medical Device Companies
For medical devices entering Canada through the exceptional importation and sale mechanism, companies and importers should focus on the following:
- Use the updated online forms to submit applications or arrival notifications;
- Prepare foreign marketing authorisations, QMS certifications, intended use and safe use information in advance;
- Fully explain the Canadian market shortage situation and the rationale for the proposed substitute product;
- Confirm the proposed import quantity and final import date for each device identifier;
- Establish and document written procedures covering sales records, complaints, incident reporting, serious risk information and recalls;
- Note that the FRM-0578 notification period has been changed to 3 working days before arrival;
- Confirm lot numbers and expiry dates for imported products in advance.
This update refines the reporting and tracking requirements for exceptionally imported medical devices. Companies should adopt the new forms promptly, prepare complete documentation and submit arrival notifications on time to avoid impacts on applications and import arrangements caused by incomplete information or late notification. If you have any questions, please feel free to contact us.